CA2206670C - Proteines du plasma sanguin traitees thermiquement - Google Patents

Proteines du plasma sanguin traitees thermiquement Download PDF

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Publication number
CA2206670C
CA2206670C CA002206670A CA2206670A CA2206670C CA 2206670 C CA2206670 C CA 2206670C CA 002206670 A CA002206670 A CA 002206670A CA 2206670 A CA2206670 A CA 2206670A CA 2206670 C CA2206670 C CA 2206670C
Authority
CA
Canada
Prior art keywords
fibrinogen
protein
heat treatment
cryoprecipitatable
heat
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA002206670A
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English (en)
Other versions
CA2206670A1 (fr
Inventor
Ronald Vance Mcintosh
John Charles Hardy
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bio Products Laboratory Ltd
Original Assignee
National Health Service Scotland
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by National Health Service Scotland filed Critical National Health Service Scotland
Publication of CA2206670A1 publication Critical patent/CA2206670A1/fr
Application granted granted Critical
Publication of CA2206670C publication Critical patent/CA2206670C/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/10—Transferases (2.)
    • C12N9/1025—Acyltransferases (2.3)
    • C12N9/104—Aminoacyltransferases (2.3.2)
    • C12N9/1044—Protein-glutamine gamma-glutamyltransferase (2.3.2.13), i.e. transglutaminase or factor XIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/04—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/106—Fibrin; Fibrinogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/75—Fibrinogen
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials
    • A61L2103/09—Blood or products thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biochemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Epidemiology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Diabetes (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Un fibrinogène lyophilisé est produit, lequel est soumis à un traitement thermique virocide total afin d'inactiver les virus présents tout en conservant des propriétés biologiques recherchées. Le fibrinogène lyophilisé à notamment une solubilité dans l'eau ou dans une autre solution aqueuse allant jusqu'à 40 g/l en moins de 20 minutes à 20 DEG , et un temps de coagulation de moins de 10 secondes lorsqu'il est exposé à au moins 200 U/ml de thrombine. Le produit peut être soumis à un traitement thermique à 80 DEG C pendant 72 heures, jusqu'à 100 DEG C pendant 10 heures, en fonction de sa formulation et de sa teneur en eau. Au cours du processus de production, le cryoprécipité est lavé avec une solution de polyéthylèneglycol entre 4 et 10 DEG C et au pH compris entre 6,8 et 8, de faible force ionique, avant d'être soumis à une cryodessication en deux étapes.
CA002206670A 1994-12-08 1995-12-08 Proteines du plasma sanguin traitees thermiquement Expired - Lifetime CA2206670C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB9424732.7A GB9424732D0 (en) 1994-12-08 1994-12-08 Heat treated blood plasma proteins
GB9424732.7 1994-12-08
PCT/GB1995/002902 WO1996017631A1 (fr) 1994-12-08 1995-12-08 Proteines du plasma sanguin traitees thermiquement

Publications (2)

Publication Number Publication Date
CA2206670A1 CA2206670A1 (fr) 1996-06-13
CA2206670C true CA2206670C (fr) 2008-02-19

Family

ID=10765577

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002206670A Expired - Lifetime CA2206670C (fr) 1994-12-08 1995-12-08 Proteines du plasma sanguin traitees thermiquement

Country Status (10)

Country Link
US (1) US5831027A (fr)
EP (1) EP0804254B1 (fr)
JP (2) JP4181214B2 (fr)
AT (1) ATE233576T1 (fr)
CA (1) CA2206670C (fr)
DE (1) DE69529845T2 (fr)
DK (1) DK0804254T3 (fr)
ES (1) ES2193206T3 (fr)
GB (1) GB9424732D0 (fr)
WO (1) WO1996017631A1 (fr)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5837519A (en) * 1996-11-21 1998-11-17 Bayer Corporation Dry-heat viral inactivation under controlled moisture conditions
ATE439150T1 (de) 1997-11-17 2009-08-15 Haemacure Corp Ein hyaluronsäurederivat enthaltende fibrinsiegel-oder fibrinklebmasse
ES2156731B1 (es) * 1999-05-31 2002-02-16 Grifols Grupo Sa Utilizacion del acido tranexamico para la preparacion de una composicion de fibrinogeno humano.
JP2001270900A (ja) * 2000-03-23 2001-10-02 Nihon Pharmaceutical Co Ltd フィブリノゲンのウイルス不活化法
GB0216001D0 (en) 2002-07-10 2002-08-21 Nat Blood Authority Process and composition
FR2857267B1 (fr) * 2003-07-09 2006-03-10 Lab Francais Du Fractionnement Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
FR2887883B1 (fr) 2005-06-29 2007-08-31 Lab Francais Du Fractionnement Procede de separation des proteines fibrinogene, facteur xiii et colle biologique d'une fraction plasmatique solubilisee et de preparation de concentres lyophilises desdites proteines
FR2894830B1 (fr) * 2005-12-19 2008-04-04 Lab Francais Du Fractionnement Procede d'inactivation virale par chauffage a sec selon la temperature de transition vitreuse
US9110008B2 (en) * 2010-07-26 2015-08-18 Los Gatos Research Method for isotopic analysis of water in bodily fluids
US20140287044A1 (en) * 2011-03-04 2014-09-25 Rare Antibody Antigen Supply, Inc. Fibrin sealant (fibringluraas) consisting of a kit of lyophilized or frozen high concentrate fribinogen
WO2019074886A1 (fr) 2017-10-09 2019-04-18 Terumo Bct Biotechnologies, Llc Récipient de lyophilisation et son procédé d'utilisation
US11754478B2 (en) 2018-08-16 2023-09-12 Abb Schweiz Ag Rapid equilibrator for water isotope analysis
US11609042B2 (en) 2019-03-14 2023-03-21 Terumo Bct Biotechnologies, Llc Multi-part lyophilization container and method of use
CN118344463B (zh) * 2024-05-15 2024-12-13 广东丹霞生物制药有限公司 一种人纤维蛋白原的制备方法及产品

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4456590B2 (en) * 1981-11-02 1989-05-30 Heat treatment of lyphilized blood clotting factor viii concentrate
US4650858A (en) * 1983-03-21 1987-03-17 Nordisk Gentofte A/S Concentrate of the antihemophilic factor VIII and a process for producing it
AT390001B (de) * 1984-09-28 1990-03-12 Immuno Ag Verfahren zur inaktivierung von vermehrungsfaehigen filtrierbaren krankheitserregern
ATE52922T1 (de) * 1985-08-05 1990-06-15 Immuno Ag Verfahren zur herstellung von praeparationen auf basis von blutgerinnungsfaktoren.
CA1293941C (fr) * 1985-11-08 1992-01-07 Maria Erlinda Co-Sarno Methode pour preparer un facteur antihenophile (fah) par precipitation a froid et pour ameliorer la solubilite du fah recupere
EP0413687A1 (fr) * 1987-05-15 1991-02-27 Alan I. Rubinstein Procede sequentiel ameliore pour le traitement de produits de facteurs de coagulation du sang humain
US5099002A (en) * 1987-05-15 1992-03-24 University Of Southern California Sequential improved method for treatment of human blood-clotting factor products
DK708488D0 (da) * 1988-12-20 1988-12-20 Nordisk Gentofte Faktor i praeparat
USH1509H (en) * 1989-06-09 1995-12-05 Eran; Harutyun Heparin enhanced process for separating antihemophilic factor (Factor VIII) and fibronectin from cryoprecipitate
AT402788B (de) * 1993-08-03 1997-08-25 Immuno Ag Virussichere blutgerinnungsfaktor xiii-präparation

Also Published As

Publication number Publication date
ES2193206T3 (es) 2003-11-01
JPH10510257A (ja) 1998-10-06
EP0804254B1 (fr) 2003-03-05
CA2206670A1 (fr) 1996-06-13
JP2008044963A (ja) 2008-02-28
DK0804254T3 (da) 2003-06-30
DE69529845T2 (de) 2003-12-11
AU692018B2 (en) 1998-05-28
ATE233576T1 (de) 2003-03-15
GB9424732D0 (en) 1995-02-08
EP0804254A1 (fr) 1997-11-05
AU4183296A (en) 1996-06-26
DE69529845D1 (de) 2003-04-10
WO1996017631A1 (fr) 1996-06-13
US5831027A (en) 1998-11-03
JP4181214B2 (ja) 2008-11-12

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